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The Food and Drug Administration’s first analysis of the clinical trial data also found that the coronavirus vaccine worked well regardless of a volunteer’s race, weight or age. The coronavirus vaccine made by Pfizer and BioNTech provides strong protection against Covid-19 within about 10 days of the first dose, according to documents published on Tuesday by the Food and Drug Administration before a meeting of its vaccine advisory group. The finding is one of several significant new results featured in the briefing materials, which include more than 100 pages of data analyses from the agency and from Pfizer. Last month, Pfizer and BioNTech announced that their two-dose vaccine had an efficacy rate of 95 percent after two doses administered three weeks apart. The new analyses show that the protection starts kicking in far earlier. What’s more, the vaccine worked well regardless of a volunteer’s race, weight or age. While the trial did not find any serious adverse events caused by the vaccine, many participants did experience aches, fevers and other side effects. “This is what an A+ report card looks like for a vaccine,” said Akiko Iwasaki, an immunologist at Yale University.
On Thursday, F.D.A.’s vaccine advisory panel will discuss these materials in advance of a vote on whether to recommend authorization of Pfizer and BioNTech’s vaccine. Pfizer and BioNTech began a large-scale clinical trial in July, recruiting 44,000 people in the United States, Brazil and Argentina. Half of the volunteers got the vaccine, and half got the placebo. New coronavirus cases quickly tapered off in the vaccinated group of volunteers about 10 days after the first dose, according to one graph in the briefing materials. In the placebo group, cases kept steadily increasing. The vaccine’s swift impact could benefit not just the people who get it but the country’s strained hospitals, curbing the flow of new patients into intensive care units. Despite the early protection afforded by the first dose, it’s unclear how long that protection would last on its own, underscoring the importance of the second dose. Previous studies have found that the second dose of the Pfizer-BioNTech vaccine gives the immune system a major, long-term boost, an effect seen in many other vaccines.
The efficacy of the vaccine after the first dose is about 52 percent, according to Dr. William C. Gruber, senior vice president of Pfizer Vaccine Clinical Research and Development. After the second dose, that rises to about 95 percent. “Two doses of vaccine provide maximum protection,” he said. Many experts have expressed concern that the coronavirus vaccines might protect some people better than others. But the results in the briefing materials indicate no such problem. The vaccine has a high efficacy rate in both men and women, as well as similar rates in white, Black and Latino people. It also worked well in obese people, who carry a greater risk of getting sick with Covid-19. Some vaccines for other diseases set off a weak immune response in older adults. But Pfizer and BioNTech found that people over 65 got about as much protection from the coronavirus vaccine as younger people did. Even if the vaccine is authorized by the F.D.A., the trial will continue. In the briefing documents, the companies said that they would encourage people to stay in the trial as long as possible, not knowing whether they got the vaccine or the placebo, so that the researchers could continue to collect information about whether the vaccine was safe and effective...
FDA documents for Dec. 10 meeting available here:
